RecruitingNot ApplicableNCT06978127

Technology Assisted Collaborative Care Intervention to Improve Patient-centered Outcomes in Dialysis Patients

Technology Assisted Collaborative Care Intervention (TĀCcare) 2.0 Implementation Trial to Improve Patient-centered Outcomes in Patients on Hemodialysis


Sponsor

University of Pittsburgh

Enrollment

424 participants

Start Date

Aug 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this study is to learn if a collaborative care intervention of pharmaco-therapy and/or cognitive behavioral therapy (CBT), delivered in a real-world setting, improves symptoms of pain, fatigue and/or depression.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a technology-assisted care program to help people on regular dialysis (three times per week) manage their care better and improve their quality of life. The program connects patients with a care team through digital tools to support decision-making and address patient concerns between clinic visits. **You may be eligible if...** - You are 18 or older - You have been on dialysis (hemodialysis) three times per week for more than 3 months - You speak English or Spanish - You are able to give informed consent **You may NOT be eligible if...** - You have active psychosis, delusions, or active suicidal thoughts - You have active substance abuse - You are enrolled in hospice care or have a life expectancy under 6 months - You are too unwell or have significant cognitive impairment - You have a kidney transplant scheduled within the next 3 months - You are receiving active treatment for cancer - You are already in another research study - You plan to switch to home dialysis or move to another dialysis center within 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALTechnology Assisted Stepped Collaborative Care

The TĀCcare 2.0 intervention will provide pharmacotherapy recommendations and/or CBT for pain, fatigue and depression. A stepped-treatment approach will be used to intensify treatment. CBT will be provided through 12 weekly telehealth sessions (done during dialysis treatment or from home) with the behavioral specialist. Booster sessions will be used to enhance the maintenance of effect following the initial intervention to complete a total 12 month intervention. A collaborative care approach will be used so that patients' symptom management will be integrated with their dialysis treatment. Throughout the study, participants will be asked to complete phone surveys about their symptoms and health.

OTHERUsual Care Arm

Participants in the Usual Care Arm will continue with their usual care.


Locations(2)

UNM

Albuquerque, New Mexico, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

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NCT06978127


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